Sarcoma, Soft TissuePREDICTNCT01995981
Individualizing Pazopanib Therapy by exploRing the Role of Early Metabolic responsE and Drug Exposure as a preDICTor for Treatment Outcome in Patients With STS
An observational study of Sarcoma, Soft Tissue, run by Radboud University Medical Center at 2 sites in 2 countries.
Trial summary
This study is a phase IV post registration prospective observational feasibility study in patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Pazopanib
- How many people
- 22 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2013to 10 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced soft tissue sarcoma who have an indication for pazopanib treatment.
Who may be able to join
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
- Age ≥ 18 years. Patients aged 66-69 are eligible for the imaging arm of the study, however they are excluded from the assessment of altered pharmacokinetic behavior in elderly.
- Histological confirmed diagnosis of selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. The following subtypes are eligible:
- Fibroblastic, so-called fibrohistiocytic, leiomyosarcoma, malignant glomus tumours, skeletal muscles, vascular, uncertain differentiation. The following subtypes are NOT eligible: Adipocytic sarcoma (all subtypes), all rhabdomyosarcoma that were not alveolar or pleomorphic, chondrosarcoma, osteosarcoma, Ewing tumours/primitive neuroectodermal tumor, GIST, dermatofibrosarcoma protuberance, inflammatory myofibroblastic sarcoma, malignant mesothelioma and mixed mesodermal tumours of the uterus.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Measurable disease criteria (RECIST 1.1).
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- No radio-, chemo- or tumor specific targeted therapy within the last 4 weeks prior to study entry.
- Adequate organ system function as defined in the research protocol.
- Minimal evaluable lesion of ≥ 15mm.
Who cannot join
- Prior malignancy.
- Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 months time interval.
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including.
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including.
- Corrected QT interval (QTc) > 480msecs.
- History of any one or more of the following cardiovascular conditions within the past 6 months:
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- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Coronary artery bypass graft surgery
- Symptomatic peripheral vascular disease
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- Poorly controlled hypertension
- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding diathesis.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
- Recent hemoptysis.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- Unable or unwilling to discontinue use of prohibited medications listed in the research protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
- Concurrent use of other substances known or likely to interfere with the pharmacokinetics of pazopanib
- Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Pazopanib.
- Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment.
- Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia.
- For FDG-PET imaging part of the study:
- uncontrolled diabetes mellitus
- only evaluable tumors in brain or urinary tract, as these cannot be evaluated by FDG-PET scan.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6525 GA
About this study
This study is a phase IV post registration prospective observational feasibility study in patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide.
- This study looks at the possibility of using 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography PET scans as an early biomarker of pazopanib treatment effect in patients.
- It also studies pazopanib pharmacokinetics to see if there are differences between elderly and younger patients.
Read more
The primary objectives are:
- To evaluate whether early metabolic response is correlated to clinical benefit.
- To evaluate the effect of age (≥ 70 years) on pazopanib pharmacokinetics.
The secondary objectives are:
- To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with pazopanib exposure.
- To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with the histological subtypes.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- Pazopanib
- Keywords
- Sarcoma, Soft Tissue, Pazopanib, Positron-Emission Tomography, Pharmacokinetics, Biomarker
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Votrient
| Study group | Role | What they receive |
|---|---|---|
| Advanced soft tissue sarcoma patients | Advanced soft tissue sarcoma patients, who have an indication for pazopanib treatment. Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) uptake
Measured: baseline, 2 weeks and 8 weeks after start treatment
Pharmacokinetics (AUC)
This measurement is performed at 2 weeks and 8 weeks after start treatment
Measured: 0, 1, 2, 3, 4, 6, 8, 10, 24 hours post-dose
Secondary outcomes (1)
Adverse events (CTCAE v4.0)
Measured: 2 weeks and 8 weeks after start treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startDec 2013
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Winette van der Graaf, prof. PhD. MD, Principal investigator, Radboud University Medical CenterWim Oyen, prof. PhD. MD, Principal investigator, Radboud University Medical CenterNielka van Erp, PharmD. PhD., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995981
- Sponsor's protocol ID
- UMCN-ONCO-201303
- Other IDs
- 2013-003533-16
- Acronym
- PREDICT
- Status last verified
- Jun 2015
- First submitted
- 21 Nov 2013
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schoffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16.
PubMed 22595799
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Pazopanib Therapy by exploRing the Role of Early Metabolic responsE and Drug Exposure as a preDICTor for Treatment Outcome in Patients With STS
- ClinicalTrials.gov ID
- NCT01995981
- Acronym / sponsor ID
- PREDICT / UMCN-ONCO-201303
- Conditions
- Sarcoma, Soft Tissue
- Keywords
- Sarcoma, Soft Tissue, Pazopanib, Positron-Emission Tomography, Pharmacokinetics, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2013 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase IV post registration prospective observational feasibility study in patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide.
- This study looks at the possibility of using 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography PET scans as an early biomarker of pazopanib treatment effect in patients.
- It also studies pazopanib pharmacokinetics to see if there are differences between elderly and younger patients.
The primary objectives are:
- To evaluate whether early metabolic response is correlated to clinical benefit.
- To evaluate the effect of age (≥ 70 years) on pazopanib pharmacokinetics.
The secondary objectives are:
- To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with pazopanib exposure.
- To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with the histological subtypes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced soft tissue sarcoma patients | – | Drug: PazopanibAdvanced soft tissue sarcoma patients, who have an indication for pazopanib treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced soft tissue sarcoma who have an indication for pazopanib treatment.
Key inclusion criteria (9 listed)
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
- Age ≥ 18 years. Patients aged 66-69 are eligible for the imaging arm of the study, however they are excluded from the assessment of altered pharmacokinetic behavior in elderly.
- Histological confirmed diagnosis of selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. The following subtypes are eligible:
- Fibroblastic, so-called fibrohistiocytic, leiomyosarcoma, malignant glomus tumours, skeletal muscles, vascular, uncertain differentiation. The following subtypes are NOT eligible: Adipocytic sarcoma (all subtypes), all rhabdomyosarcoma that were not alveolar or pleomorphic, chondrosarcoma, osteosarcoma, Ewing tumours/primitive neuroectodermal tumor, GIST, dermatofibrosarcoma protuberance, inflammatory myofibroblastic sarcoma, malignant mesothelioma and mixed mesodermal tumours of the uterus.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (27 listed)
- Prior malignancy.
- Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 months time interval.
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including.
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including.
- Corrected QT interval (QTc) > 480msecs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibAlso: Votrient | Drug | Advanced soft tissue sarcoma patients |
Primary outcome
FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) uptake
Time frame: baseline, 2 weeks and 8 weeks after start treatment
Pharmacokinetics (AUC)
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 24 hours post-dose
This measurement is performed at 2 weeks and 8 weeks after start treatment
1 secondary outcome
Adverse events (CTCAE v4.0)
Time frame: 2 weeks and 8 weeks after start treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Background: PubMed 22595799van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schoffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winette van der Graaf, prof. PhD. MD principal investigator
Radboud University Medical Center
Wim Oyen, prof. PhD. MD principal investigator
Radboud University Medical Center
Nielka van Erp, PharmD. PhD. principal investigator
Radboud University Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, Soft Tissue, run by Radboud University Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) uptake (time frame: baseline, 2 weeks and 8 weeks after start treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.